Cabotegravir And Rilpivirine: Efficacy and Safety Study (CARES) is a research project that aims to make taking medication easier for people living with HIV in sub-Saharan Africa. Many people on combination anti-retroviral therapy (cART) must take many pills each day to maintain their health and well-being. CARES offers an alternative: injectable medication taken 6 times per year. Because this regimen offers the benefit of reduced dosing from daily pills to injections every 2 months, the study is expected to demonstrate whether this could have a positive impact on the patient’s quality-of-life, improve adherence to treatment, improve engagement in care and reduce the stigma associated with the daily use of oral pills.
A randomized clinical trial is currently underway in three sub-Saharan African countries (Kenya, South Africa, and Uganda) to demonstrate the safety and efficacy of taking injectable anti-retroviral treatment every two months instead of taking oral medicine each day in virologically suppressed adults for a period of 24 months.
The project started enrolling participants on 15th September 2021. Adults living with HIV (n=512) were randomly selected to continue taking first-line cART or asked to start taking injectable, long-acting Cabotegravir and Rilpivirine (CAB + RPV LA)
The primary aim of CARES is to show that switching to injectable medicine works just as well as taking pills for HIV treatment in a resource limited setting.
Secondary aims are:
Who is part of CARES
The CARES project screened over 1000 participants across 3 clinic sites in Kenya, 3 clinic sites in Uganda, and 2 clinic sites in South Africa to enroll 512 participants. The study is a collaborative effort between research teams sponsored by JCRC Uganda funded by Janssen.